MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C7461
Medical Device Problem Codes	Material Twisted/Bent (2981); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink system secondary medication set had crinkles and were not allowing the liquid to flow through properly.This was discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction made to g3: date received by mfr: 11/13/2023 (previously submitted as 11/14/2023).H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SECONDARY MEDICATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18311661
• Report Number: 1416980-2023-06463
• Device Sequence Number: 15133047
• Product Code: FPA
• UDI-Device Identifier: 00085412049069
• UDI-Public: (01)00085412049069
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2C7461
• Device Lot Number: SR22L13003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown